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Evaluating a Pharmacokinetic Drug Interaction Between Metformin Hydrochloride and Rosuvastatin Calcium

NCT ID: NCT01775579

Last Updated: 2013-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-06-30

Brief Summary

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We investigate the potential pharmacokinetic drug-drug interaction between metformin extended release and rosuvastatin in healthy male volunteers who receive metformin extended release alone, rosuvastatin alone, and both together in a 3 period repeatedly.

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Crestor tablet 20 mg

Crestor tablet 20 mg single---\>wash out----\>Glucophage SR tablet 750 mg single----\>washout---\>Glucophage SR tablet 750 mg, Crestor tablet 20 mg both

Group Type EXPERIMENTAL

Glucophage SR tablet 750 mg, Crestor tablet 20 mg

Intervention Type DRUG

Glucophage SR tablet 750 mg and Crestor tablet 20 mg both

Glucophage SR tablet 750 mg, Crestor tablet 20 mg both---\>wash out----\>Glucophage SR tablet 750 mg single------\>washout---\>Crestor tablet 20 mg single

Group Type EXPERIMENTAL

Glucophage SR tablet 750 mg, Crestor tablet 20 mg

Intervention Type DRUG

Glucophage SR tablet 750 mg

Glucophage SR tablet 750 mg single ---\>wash out----\>Crestor tablet 20 mg single----\>washout---\>Glucophage SR tablet 750 mg, Crestor tablet 20 mg both

Group Type EXPERIMENTAL

Glucophage SR tablet 750 mg, Crestor tablet 20 mg

Intervention Type DRUG

Interventions

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Glucophage SR tablet 750 mg, Crestor tablet 20 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy male volunteers, age 20 to 55 years.
2. The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
2. Glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value.
3. Liver enzyme (AST, ALT) level exceeds one and a half times more than maximum normal range.
4. Systolic blood pressure \<90mmHg or Diastolic blood pressure \< 60 mmHg, systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg(Sitting blood pressure) during the screening procedure.
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Samgsung Seoul Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HM-MERO-101

Identifier Type: -

Identifier Source: org_study_id